Associate Director, Biostatistics

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Job Summary:

The Associate Director of Biostatistics will be responsible for oversight and input on statistical design, data analysis, and regulatory interactions for all MannKind programs. The ideal candidate combines deep technical expertise with collaborative leadership and brings a strong track record of supporting clinical development. This position will act as the leading statistician on multiple studies/projects across different therapeutic areas. This is a unique opportunity for a biostatistics leader who’s looking to make a significant impact in a fast-moving, high-growth environment.

Responsibilities:

• Provide input to protocol and study design, Statistical sections and study objectives, adaptive designs, endpoints, estimands, sample size computation and power estimations
• Development of Randomization Plans, including generation of mock and final randomization lists. Collaborate with team re: implementation of specifications for randomization system set up
• Participate in the development of Bioanalytical Plans, PK Analysis Plans and PK Data Transfer Agreements
• Provide key input to project DSMB Charters, Blinding and Unblinding Plans, Statistical Analysis Plans, and study drug compliance calculations
• Review of protocol deviations in conjunction with populations assignments; review TLF and shells; review and approval of CSRs; review and approval of overall submission packages (SDTM and ADaM datasets)
• Work with Statistical Programmer to develop specifications for datasets in conjunction with the SAP and submission package
• Review of key results and statistical assessment in preparation of publications and regulatory submissions (IBs, Protocols, Clinical Summaries, IRs, Briefing Documents, DSURs, Integrated Safety and Efficacy Summaries, etc.). Attend prep meetings and participate in Agency meetings as requested
• Provide statistical expertise in development of MannKind data collection standards
• Provide input into annual budget estimations
• Manage CRO and contract statisticians
• Attend project and study team meetings as needed. Support and participate in activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected
• Provide statistical expertise by identifying potential issues, providing recommendations and bring in external statistical experts for relevant issues as needed
• Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP), and industry standards in statistical analysis and reporting
  
  

Qualifications:

• Master's Degree PhD or MS in Statistics, Biostatistics or other Scientific discipline
• Minimum of 10 years of experience in statistical analysis for clinical trials, preferably in the pharmaceutical or clinical research industry
• Proficiency in statistical analysis software (e.g., SAS)
• Experience with statistical programming and the development of TLF
• Excellent communication skills, with the ability to effectively communicate statistical concepts to non-statisticians
• Strong collaboration skills with cross-functional teams
• Familiarity with regulatory requirements for clinical trial conduct and reporting
• Flexible and able to support a variety of studies
• Ability to act independently and with initiative
• Knowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding Biostatistics
  
  

Pay Range: $144,000 - $216,000 per year